Clinical Project Manager, Clinical Adjudication

Are you seeking a purposeful and rewarding Project Management career opportunity within a team dedicated to specialty solutions for clinical trials?

Our Clinical Adjudication team is expanding in India, and with ambitious goals and a clear vision for the future, now is the perfect time to join Clario as a Clinical Project Manager. In this role, you will be part of a team dedicated to ensuring unbiased and standardized evaluation of clinical trial events, contributing to the credibility and success of our studies. Join us and make a meaningful impact in the field of clinical research.

What we offer

• Competitive compensation + shift allowances
• Attractive benefits (security, flexibility, support and well-being)
• Engaging employee programs
• Technology for hybrid working and great onsite facilities

What you'll be doing

Identifies project guidelines and communication needs by:

• Reviewing study requirements and response assessment criteria and collaborates with key stakeholders to develop study start-up activities and associated documents
• Defining project plans (i.e. timelines, milestones and limitations for project staff)
• Establishing project reporting schedules
• Providing project updates to BD Director, Global Services Managing Directors, Sponsor representative(s) on schedule
• Communicating timely, appropriate project information to project teams, sites and company/sponsor representative(s)

Performs project analysis and management by:

• Identifying critical project success factors for tracking, analysis and reporting
• Determining needed resources for project completion and communicating needs to appropriate departmental managers
• Collaborating with department leaders for appropriate training of those involved with the project toward excellence in successful and timely completion of project
• Performing financial tasks including monthly billing, forecasting, project scope reviews and amendments, and pass-through cost management
• Possessing a thorough understanding of the project contract and totals needed for monthly revenue reporting
• Understanding SOPs and working closely with QA for clarification and documentation of deviations
• Training and maintaining project team knowledge and applications of SOPs
• Communicating all protocol clarifications/revisions to project team
• Coordinating site management of data collection with internal and external teams

Provides project team leadership by:

• Leading by example with professional and collaborative conduct
• Developing and delivering team project training
• Establishing team performance expectations and guidelines
• Providing input to departmental managers of respective team members performance level
• Analyzing team performance for consistency/quality within established project guidelines
• Collaborating with the departmental managers for team coaching/mentoring

Supports Business Development efforts by:

• Collaborating with BD Director in the development and presentation of company capabilities calls/meetings
• Attending professional meeting(s) as Company representative
• Delivering polished Investigator Meeting presentation projecting solid comprehension of project/protocol and company services

Oversees project close out by:

• Assisting with coordination of submission activities, as applicable
• Assisting with initiating and overseeing all project close out activities to completion

Performs supervisory functions by, if applicable:

• Communicating job expectations
• Planning, monitoring and appraising job results
• Coaching, counseling and disciplining staff
• Initiating, coordinating and enforcing systems, policies and procedures
• Approving direct reports time sheets, requests for time off and/or overtime
• Performing timely performance evaluations of direct reports
• Coordinating and conducting new hire interviews; facilitating hiring decision
• Training new hires on departmental processes and responsibilities

Maintains Quality Service and Departmental Standards by:

• Reading, understanding and adhering to organizational Standard Operating Procedures (“SOP”)
• Establishing and enforcing departmental standards
• Reviewing and updating company SOPs related

What we look for

• Bachelor’s degree required or commensurate experience level.  Educational majors in life sciences, pharmacy, nursing, or other healthcare field highly desirable
• Previous management or project experience in clinical development of investigational medications required
• 1-3 years clinical trials experience within a CRO or pharmaceutical research organization required; preferably in a project management related role.
• Working knowledge of GCH, ICH guidelines and FDA regulations
• Clinical Adjudication experience a plus
• Experience working with computer software including Word, Excel, Access and Project preferred
• Strong interpersonal and communication skills, both verbal and written
• Strong organizational and leadership skills
• Goal oriented
• Ability to maintain professional and positive attitude